The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is-dsdna Test System.
| Device ID | K974694 |
| 510k Number | K974694 |
| Device Name: | IS-DSDNA TEST SYSTEM |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Lynne Stirling |
| Correspondent | Lynne Stirling DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-16 |
| Decision Date | 1998-03-03 |
| Summary: | summary |